Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus (EBV)-Positive Nasopharyngeal Cancer (NPC) and Other Epstein-Barr Virus (EBV)-Associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies


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Trial ID: NCT04925544


To evaluate the anti cancer effect of VK 2019 in subjects with EBV related nasopharyngeal carcinoma (NPC) for whom there is no other standard treatment available

Official Title

Phase 2, Open-label, Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus Positive Nasopharyngeal Cancer (NPC) and Other EBV-associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   - 1 Informed consent obtained prior to any protocol mandated study specific procedures
   in accordance with institutional policies.

   - 2 Either loco regionally recurrent or metastatic EBV positive RECIST evaluable
   nasopharyngeal carcinoma not amenable to curative treatment with no accepted effective
   standard of care therapeutic option.

Addendum for phase 2 exploratory cohorts: subjects with PTLD or EBV lymphoma not amenable
to curative treatment with no accepted effective standard of care therapeutic option.

   - 3 Not eligible for other approved or standard therapies

   - 4.Prior palliative radiation must have been completed at least 2 weeks prior to study
   Cycle 1 Day 0

   - 5.Prior anti cancer systemic treatment must have been completed greater than 4 weeks
   prior to the first dose of VK 2019 or subjects must have recovered from all acute
   prior treatment related AEs

   - 6.Toxicities related to prior anti cancer therapy must have returned to Grade 1 or
   less. Peripheral neuropathy must be Grade 2 or less. Chronic but stable toxicities
   Grade > 1 (eg, dysphasia, G tube dependence, etc.) are permissible.

   - 7.Age ≥ 18

   - 8.Absolute neutrophil count > 1500/µL (stable off any growth factor for at least 1
   week of study drug administration)

   - 9.Hemoglobin > 9g/dL (transfusion to achieve this level is permitted)

   - 10.Platelet count > 75 x 103/ µL (transfusion to achieve this level is NOT permitted)

   - 11.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x
   upper limit of normal (ULN) .Total serum bilirubin ≤ 1.5 x ULN

   - 12.Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min as calculated per
   Cockcroft Gault equation

   - 13.Urinary protein < 2+ by dipstick. If dipstick ≥ 2+, then a 24 hour urine collection
   can be done and the subject may enter only if urinary protein is < 1 g/24 hour

   - 14.Sexually active subjects must agree to utilize birth control method during
   treatment and for 18 weeks after the last dose of VK 2019.

   - 15.Eastern Cooperative Oncology Group (ECOG) performance status 2 or less.

   - 16.Ability to understand and the willingness to personally sign the written IRB
   approved informed consent document.

Exclusion Criteria:

   - 1.Prior therapy restrictions.

   - 2.Concurrent treatment with systemic cancer directed therapy including complementary,
   alternative, herbal or nutritional supplement based treatments whose purpose is for
   anti cancer effect

   - 3.Severe or active symptomatic cardiopulmonary diseases, including unstable angina,
   congestive heart failure, or peripheral vascular disease within 12 months prior to
   study drug administration; and/or chronic obstructive pulmonary disease exacerbation
   or other respiratory illness requiring hospitalization within 4 weeks prior to study
   drug administration. Subjects with effectively treated conditions (eg, stenting for
   coronary artery disease) are eligible if stable for at least 4 weeks prior to study
   drug administration

   - 4.Metastatic disease with active central nervous system (CNS) involvement, defined as
   parenchymal brain involvement. Subjects with cranial nerve or base of skull
   involvement without the above are eligible. Subjects with CNS metastases that are
   stable on imaging at least 1 month following focal treatment with radiation are

   - 5.Known history of human immunodeficiency virus (HIV) unless the HIV positive subjects

      1. A stable regimen of highly active anti retroviral therapy (HAART)

      2. No requirement for concurrent antibiotics or antifungal agents for the prevention
      of opportunistic infections

      3. A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard
      PCR based test

   - 6.Serious uncontrolled medical disorder or active infection which would, in the
   opinion of the Investigator, impair the ability of the subject to receive protocol
   therapy or whose control may be jeopardized by the complications of this therapy

   - 7.NPC subjects: Have received a prior organ allograft or allogeneic bone marrow

   - 8.Current non prescription drug or alcohol dependence

   - 9.For all female subjects: pregnancy or breastfeeding

   - 10.All female subjects with reproductive potential must have a negative pregnancy test
   (serum or urine) prior to enrollment

   - 11.Other severe acute or chronic medical or psychiatric condition or laboratory
   abnormality that may increase the risk associated with study participation or study
   drug administration, or may interfere with the interpretation of study results, or in
   the judgment of the investigator would make the subject inappropriate for entry into
   the study

   - 12.Corrected QT by Fridericia's formula (QTcF) of > 470 ms average (mean) on
   triplicate ECG performed during screening


drug: VK-2019


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters

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